ECTOPIA: Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment
Study Details
Study Description
Brief Summary
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Sotalol
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Drug: Sotalol
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
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Active Comparator: Flecainide and verapamil
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Drug: Flecainide and verapamil
Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day
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Active Comparator: Catheter ablation
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Procedure: Catheter ablation
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
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Outcome Measures
Primary Outcome Measures
- Successful therapy [After 3 months]
Number of patients reaching succesfull therapy defined as >80% reduction of of VPB/VT burden after 3 months
Secondary Outcome Measures
- VPB/VT burden [3, 6, 12 months after intervention]
- Change in VPB/VT burden [Before the intervention (baseline) and 3, 6, 12 months after intervention]
Measurement in different subgroups e.g.: males, pre and post-menopausal women
- The impact in terms of total Quality of Life [3, 6, 12 months after intervention compared to baseline (before intervention)]
Use of the University of Toronto AF severity scale (AFSS) questionnaire to measure Quality of Life. The total score range is 0-35. Seven questions in total with a maximum score of 5 points per question.
- Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring [At baseline]
A scatterplot will be made in order to depict the association between the number of VBP/hour and heart rate (HR)/hour during 24-hour Holter-monitoring
- Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring [3, 6 and 12 months after intervention]
- QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test [4-6 weeks after first administration of AAD]
- Complication rate of catheter ablation [Procedure and 3, 6 and 12 months after intervention]
In all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs
- Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement) [Baseline, 6 and 12 months after intervention]
- Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil [3, 6 and 12 months after intervention]
- Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil [3, 6 and 12 months after intervention]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients willing and capable to provide written informed consent
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Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND
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Absence of structural heart disease (excluded by echocardiogram) AND
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Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND
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Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.
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For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study
Exclusion Criteria:
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Age >75 years
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Previous catheter ablation therapy for VPB/VT
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Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
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Wolff-parkinson-white (WPW) syndrome
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Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.
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Left ventricular dysfunction (LV ejection fraction <55%)
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Estimated glomerular filtration rate < 50 ml/min/1.73 m2
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Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening
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Untreated hypo- or hyperthyroidism or electrolyte imbalance
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Untreated obstructive sleep apnea
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Patients with history of myocardial infarction or bypass surgery
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More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)
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Contraindication for any of the antiarrhythmic drugs used in this study
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Enrolment in another clinical study
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Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age
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Mental or physical inability to participate in the study
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Life expectancy ≤ 12 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Isala hospital | Zwolle | Netherlands |
Sponsors and Collaborators
- Maatschap Cardiologie Zwolle
Investigators
- Principal Investigator: Arif Elvan, MD, PhD, Isala
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10407